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Tempus IC2 Li-ion Battery

by Remote Diagnostic Technologies Ltd.

Ref 01-2029 / 989706010160

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152124↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506047244BM726VF Basic UDI-DI 05060472440594UDI-DIDate8 Jan 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05060472440594 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK152124 Date28 Oct 2015IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Tempus IC2 Li-ion Battery EUDAMED
Tempus IC2 GUDID
Generic Name
Multiple vital physiological parameter monitoring system, clinical
Device Name
Tempus Lithium-ion Battery
Model / Reference
01-2029 / 989706010160 EUDAMED
01-2029 GUDID
Primary DI / UDI-DI
05060472440594
Basic UDI-DI
506047244BM726VF
510(k) Number
FDA Product Code
MWI
EMDN Code
Z1203020299 Multi–parameter monitors - other
GMDN Term
Multiple vital physiological parameter monitoring system, clinical
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2300
EU market of registration
Luxembourg
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
01-2029 / 989706010160
GUDID
01-2029
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
GB-MF-000002127
Authorised representative
Philips Medical Systems Nederland B.V. NL-AR-000001422

Other devices from Remote Diagnostic Technologies Limited

See all devices from Remote Diagnostic Technologies Limited →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No